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Updated Pediatric ARV Guidelines

Updates to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection were released on Thursday, November 1, 2012. Please send your comments to ContactUs@aidsinfo.nih.gov by November 15, 2012.

Corrections were made to the guideline. For a description of the changes, please see the correction notice.

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Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Non-Nucleoside Analogue Reverse Transcriptase Inhibitors (NNRTIs)

Rilpivirine

(Last updated:11/1/2012; last reviewed:11/1/2012)

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Rilpivirine (RPV, Edurant, TMC 278)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Formulations
Tablet: 25 mg
Combination Tablet:
  • With emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF):
    RPV 25 mg + FTC 200 mg + TDF 300 mg (Complera)
Dosing Recommendations

Neonate/infant dose:
  • Not approved for use in neonates/infants.

Pediatric dose:

  • Not approved for use in children. A clinical trial in treatment-naive adolescents (aged 12–18 years) is under way.

Adolescent (>18 years)/adult dose (antiretroviral [ARV]-naive patients only):

  • 25 mg once daily
Selected Adverse Events
  • Depression, mood changes
  • Insomnia
  • Headache
  • Rash
  Special Instructions
  • Instruct patients to take rilpivirine with a meal of at least 500 calories (a protein drink alone does not constitute a meal).
  • Do not use rilpivirine with other non-nucleoside reverse transcriptase inhibitors.
  • Do not use rilpivirine with proton pump inhibitors.
  • Use rilpivirine with caution when co-administered with a drug with a known risk of torsade de pointes (http://www.qtdrugs.org/).
  • Use rilpivirine with caution in patients with HIV RNA >100,000 copies/mL because of increased risk of virologic failure.
Metabolism
  • Cytochrome P450 (CYP) 3A substrate
  • Dosing in patients with hepatic impairment:
    No dose adjustment is necessary in patients with mild or moderate hepatic impairment.
  • Dosing in patients with renal impairment:
    No dose adjustment is required in patients with mild or moderate renal impairment.
  • Use rilpivirine with caution in patients with severe renal impairment or end-stage renal disease. Increase monitoring for adverse effects because rilpivirine concentrations may be increased in patients with severe renal impairment or end-stage renal disease.

Drug Interactions:

  • Metabolism: Rilpivirine is a CYP 3A substrate and requires dosage adjustments when administered with CYP 3A-modulating medications.
  • Before rilpivirine is administered, a patient’s medication profile should be carefully reviewed for potential drug interactions.

Major Toxicities:

  • More common: Insomnia, headache, and rash
  • Less common (more severe):Depression or mood changes

Resistance: The International Antiviral Society-USA (IAS-USA) maintains a list of updated resistance mutations (see http://www.iasusa.org/resistance_mutations/index.html).

Pediatric Use: The pharmacokinetics, safety, and efficacy of rilpivirine in pediatric patients have not been established. An international trial currently under way is investigating a 25-mg dose of rilpivirine in combination with two nucleoside reverse transcriptase inhibitors in antiretroviral-naive children aged 12 to 18 years who weigh at least 40 kg.